US8357104B2 - Active stylet safety shield - Google Patents
Active stylet safety shield Download PDFInfo
- Publication number
- US8357104B2 US8357104B2 US11/933,864 US93386407A US8357104B2 US 8357104 B2 US8357104 B2 US 8357104B2 US 93386407 A US93386407 A US 93386407A US 8357104 B2 US8357104 B2 US 8357104B2
- Authority
- US
- United States
- Prior art keywords
- stylet
- shield
- handle
- cannula
- shaft
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active, expires
Links
- 230000007246 mechanism Effects 0.000 claims description 21
- 238000001574 biopsy Methods 0.000 claims description 16
- 238000000034 method Methods 0.000 claims description 8
- 230000006835 compression Effects 0.000 claims description 5
- 238000007906 compression Methods 0.000 claims description 5
- 230000000149 penetrating effect Effects 0.000 claims description 2
- 210000000988 bone and bone Anatomy 0.000 abstract description 26
- 210000001185 bone marrow Anatomy 0.000 description 6
- 230000000712 assembly Effects 0.000 description 5
- 238000000429 assembly Methods 0.000 description 5
- 230000001054 cortical effect Effects 0.000 description 4
- 239000000463 material Substances 0.000 description 3
- 239000007788 liquid Substances 0.000 description 2
- 239000012620 biological material Substances 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 239000006261 foam material Substances 0.000 description 1
- 231100001261 hazardous Toxicity 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0233—Pointed or sharp biopsy instruments
- A61B10/025—Pointed or sharp biopsy instruments for taking bone, bone marrow or cartilage samples
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/03—Automatic limiting or abutting means, e.g. for safety
- A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
- A61B2090/034—Abutting means, stops, e.g. abutting on tissue or skin abutting on parts of the device itself
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0801—Prevention of accidental cutting or pricking
Definitions
- the present invention relates generally to a stylet safety shield.
- Needle assemblies have particular, although not exclusive application in the field of medicine and have tubular needles with sharpened ends for use in piercing the skin to withdraw materials as needed.
- the needle is supported by some other structure that is used to manipulate the needle. The most common example is a syringe.
- some needle assemblies require the application of substantial force in use.
- One example of such a needle assembly is a bone marrow needle assembly that is used to penetrate cortical bone to reach the intramedullary canal for withdrawing liquid and/or a biopsy sample of bore marrow, or for infusing the canal with a selected material.
- the needle includes a cannula and a stylet that is received in the cannula and has a hard, sharp tip that can penetrate cortical bone.
- the tip projects out from the distal end of the cannula.
- the stylet can be withdrawn from the cannula after the needle penetrates the bone so that the hollow interior of the cannula can be used as a conduit for liquid or a receptacle to collect bone marrow.
- bone needle assemblies conventionally mount the needle in a handle that is sized and shaped so that the technician may comfortably grip the handle and apply the force necessary to penetrate the bone.
- the handle may comprise a stylet handle member 16 that mounts the stylet and a cannula handle member 18 that mounts the cannula.
- the two handle members are removably securable together to form the handle when the stylet is inserted into the cannula so that the stylet handle member 16 is in contact with the palm of the technician's hand in use, and the cannula handle member 18 receives the technician's fingers.
- one conventional type of bone needle assembly 10 includes a safety shield slidably received on the stylet for shielding the tip of the stylet.
- the stylet safety shield is releasably secured within a cavity of the cannula handle member 18 and is housed within an enclosure defined by the cavity in the cannula handle member and a cavity in the stylet handle member.
- the stylet safety shield remains secured to the cannula handle member 18 when the stylet handle member 16 is removed from the cannula handle member and the stylet is withdrawn from the cannula.
- the stylet slides through the stylet safety shield as the stylet is withdrawn from the cannula until the mechanism in the safety shield fixedly engages the stylet at the stylet tip.
- the safety shield disengages the cannula handle member, and the stylet with the shield disposed over its tip is separated from the cannula.
- the conventional stylet safety shield design described above is an easy, passive mechanism that ensures that the tip of the stylet will be covered after use and removal from the cannula
- drawbacks have been realized and identified by the applicants. For instance, a desired bone marrow sample may not be retrieved on the first attempt, requiring reuse of the needle assembly. If the shield is automatically locked over the tip, it will be very difficult to expose the tip again for use. Moreover, in attempting to re-expose the tip, the danger of a stick is greatly magnified. Thus, the passive shield may lead to the very thing it was supposed to prevent.
- a biopsy needle assembly generally comprises a cannula including a cannula handle and a cannula shaft extending outward from the handle.
- the cannula shaft has an axial passage extending through a proximal end of the shaft secured to the handle and a sharp distal tip of the shaft.
- a stylet includes a stylet handle and a stylet shaft extending outward from the stylet handle.
- the stylet shaft has a sharp distal tip and is adapted to be slidably received in the axial passage of the cannula shaft.
- the stylet handle is adapted to be releasably connected to the cannula handle when the stylet shaft is received in the cannula shaft to form a handle of the needle assembly.
- a safety shield includes a locking mechanism configurable between an unlocked configuration, in which the locking mechanism permits the shield to be moved axially along the stylet shaft when the shield is generally proximal of the tip of the stylet shaft, and a locked configuration, in which the locking mechanism substantially prevents axial movement of the shield when the shield is at a location covering the tip of the stylet shaft.
- the shield and the stylet are adapted for releasable interengagement when the stylet and cannula are connected to each other with a force greater than any force interengaging the shield and the cannula whereby the shield moves with the stylet after the stylet handle and the cannula handle are released from securement and as the stylet shaft is axially withdrawn from the cannula shaft.
- a shield release device mounted on the stylet is operable for pushing the safety shield in a direction out of the stylet handle.
- a method of using a biopsy needle assembly generally comprises penetrating the skin with a stylet needle and cannula needle of the biopsy needle assembly.
- a stylet handle mounting the stylet needle is disconnected from the cannula handle mounting the cannula needle.
- the stylet handle and needle are separated from the cannula handle and needle so that a stylet needle safety shield at least partially disposed in the stylet handle moves with the stylet handle.
- the safety shield is urged with a shield release device from a location interior of the stylet handle outward from the interior of the stylet handle.
- FIG. 1 is a perspective of a bone marrow needle assembly
- FIG. 2 is the perspective of FIG. 1 , but with a stylet of the assembly separated from a cannula;
- FIG. 3 is the perspective of FIG. 1 , but with the stylet being separated from the cannula;
- FIG. 4 is a partial fragmentary section of a needle and safety shield of the stylet showing a locking member not engaged;
- FIG. 5 is the section of FIG. 4 , but showing the locking mechanism engaged with the needle;
- FIG. 6 is a fragmentary section of the stylet showing the safety shield in a retracted position
- FIG. 7 is the section of FIG. 6 , but showing the safety shield in an extended position
- FIG. 8 is a fragmentary section of a stylet of another configuration showing a safety shield in a retracted position
- FIG. 9 is the section of FIG. 8 , but showing the safety shield in an extended position
- FIG. 10 is a fragmentary section of a stylet of another configuration showing a safety shield in a retracted position
- FIG. 11 is a fragmentary section of stylet of still another configuration showing a safety shield in a retracted position.
- the bone needle assembly includes a stylet 12 and a cannula 14 that may be releasably secured together to form the assembled bone needle assembly 10 .
- the stylet 12 and the cannula 14 each include a handle member designated at 16 and 18 , respectively, and a shaft (or “needle”), designated at 20 and 22 , respectively.
- Each of the shafts 20 , 22 is mounted on and extends outward from its corresponding handle member 16 , 18 .
- the cannula shaft 22 is generally cylindrical and defines an axial passage that is sized and shaped to removably receive the rod-shaped stylet shaft 20 so that the shafts together form a needle of the bone needle assembly 10 and the tips of the shafts together form a tip of the needle.
- the stylet handle member 16 is releasably securable to the cannula handle member 18 when the stylet shaft 20 is received in the cannula shaft 22 to form a handle of the bone needle assembly 10 .
- the handle members 16 , 18 are releasably securable by a bayonet connection that requires one of the stylet 12 and the cannula 14 to be rotated 90 degrees about a longitudinal axis to lock and unlock the handle members.
- stylet handle member 16 constitutes a proximal handle member because it is nearer to the technician during use
- cannula handle member 18 constitutes a distal handle member because it is farther from the technician during use.
- the stylet 12 includes a safety shield 26 slidably received on the stylet shaft 20 for covering a sharp tip 28 of the shaft after the stylet is separated from the cannula 14 ( FIG. 2 ).
- the safety shield 26 includes a generally tubular housing 30 and a locking mechanism (generally indicated at 32 supported within the housing.
- the locking mechanism 32 inside the safety shield 26 comprises a canting member including a base 34 having a hole and a pair of arms 36 (only one is shown) extending generally axially from the base (see, FIG. 4 ).
- the arms 36 are connected together by a U-shaped member 38 at their ends and each has an upwardly (as oriented in the figures) bent tab 40 (only one is shown) projecting axially outward from the end.
- the ends of the arms 36 ride on the exterior surface of the cannula shaft 22 .
- the base 38 can move along the stylet shaft 20 with the safety shield 26 , and the cannula shaft 22 slides unimpeded through the hole in the base.
- the locking mechanism 32 is spring biased so that the ends of the arms move in a generally radial direction toward an opposite side of the longitudinal axis of the stylet shaft 20 .
- the stylet shield 26 When bone needle assembly 10 is assembled (i.e., the stylet shaft 20 is received in the cannula shaft 22 and the handle members 16 , 18 are secured together), the stylet shield 26 is in an initial position disposed adjacent a proximal end of the stylet shaft so that a distal portion of the shield is disposed in a receptacle (not shown) formed in the proximal end of the cannula handle member and a proximal portion of the shield is disposed in a cavity 44 in the stylet handle member 16 .
- the safety shield 26 is substantially concealed within the assembled handle.
- the distal portion of the stylet safety shield 26 and the proximal end of the cannula handle member 18 are substantially free from connection with each other when the shield is received in the cannula handle member receptacle.
- the shield 26 and cannula handle member 18 can be said not to be interengaged, although they contact each other.
- the cannula handle member will not retain the shield 26 .
- the shield does have interengagement with the stylet handle member 16 .
- the locking mechanism 32 frictionally engages the stylet shaft 20 .
- the sides of the shield 26 may wedge against walls 46 defining the cavity 44 in the stylet handle member 16 (see, FIG. 6 ).
- both forms of engagement are present, but it will be understood that only one of these, or an entirely different form of interengagement may be employed within the scope of the present invention.
- the stylet shaft 20 will not slide through the safety shield 26 , but instead the stylet shield will move conjointly with the stylet shaft as the stylet shaft is axially withdrawn from the cannula shaft 22 .
- the bone needle assembly 10 of the present invention does not have a passively activated safety shield (i.e., one which covers and locks onto the stylet tip automatically when the stylet is separated from the cannula).
- a passively activated safety shield i.e., one which covers and locks onto the stylet tip automatically when the stylet is separated from the cannula.
- the technician must actively supply the necessary pushing or pulling force to slide the shield 26 distally along the stylet shaft 20 . It is understood that there may be some connection between the stylet shield 26 and the cannula handle member 18 when the needle assembly is assembled as long as the connection does not result in a counter force that is greater than the static force shield and the stylet 12 .
- a shield release device is disposed in the cavity 44 of the stylet handle member 16 to urge the shield 26 distally along the stylet shaft 20 an axial distance D (see, FIG. 7 ) from its initial position ( FIG. 6 ) within the handle member as the stylet 12 is being withdrawn from the cannula.
- the shield release device 50 of FIGS. 1-7 comprises a compression spring 52 received around the stylet shaft 20 within a receptacle 54 at the proximal end of the stylet handle member cavity 44 .
- One end of the spring 52 is secured to the stylet handle member 16 and an opposite end engages a proximal end of the shield 26 .
- the distal end of the stylet shield 26 contacts the cannula handle member to move the shield into the stylet cavity 52 and compress the spring 52 .
- FIG. 6 illustrates the stylet 12 separate from the cannula 14 , but shows the retracted position of the shield 26 with the spring 52 compressed.
- the compression spring 52 elongates or expands axially to urge the stylet shield 26 to move distally on the stylet shaft 20 the distance D to an extended position for allowing the user to more easily grasp the shield ( FIG. 7 ).
- the shield release device 50 may be of other types and configurations without departing from the scope of the present invention.
- the shield release device 50 comprises a resiliently compressible spring in the form of a tubular plug 56 received around a stylet shaft 20 within the receptacle 54 of the stylet handle member 16 .
- the plug 56 is made of a foam material, but other resiliently compressible materials may be used within the scope of the present invention.
- the shield release device 50 illustrated in FIG. 10 comprises a spring plate 60 or clip mounted in a proximal end of the stylet cavity 44 .
- FIG. 10 shows the spring plate 60 compressed, prior to pushing the shield 26 in a direction out of the cavity 44 .
- the shield release device 50 shown in FIG. 11 comprises a coil spring 64 and a wedge 66 that contacts the shield 26 .
- the coil spring 64 is a compression spring that exerts a force on the wedge 66 that is in a direction that is laterally transverse to the axial movement of the shield 26 .
- the wedge 66 partially converts the laterally transverse force exerted by the spring 64 into an axially force in the direction of the movement of the shield 26 .
- Other ways of moving a shield an axial distance from its configurations without a spring, are within the scope of the invention.
- the cannula 14 also includes a safety shield 70 for covering the distal tip of the cannula shaft 22 after use.
- the illustrated safety shield 70 of the cannula is of the type described in U.S. patent application Ser. No. 11/146,173, filed Jun. 6, 2005, the entirety of which is herein incorporated by reference. It is understood that a cannula safety shield may be of another type or the cannula may not include a safety shield within the scope of the present invention. For purposes of the present invention, the cannula safety shield 70 will not be described in further detail herein.
- the bone needle assembly 10 is driven into a selected bone by grasping the handle formed by the stylet and cannula handle members 16 , 18 , and pushing the sharp distal ends of the stylet 12 and cannula 14 through the skin, underlying tissue and cortical bone. Description of the use of the bone needle assembly 10 is made with reference to the assembly 10 configured as shown in FIGS. 1-7 . Once this penetration has been achieved, the stylet 12 is no longer required.
- the stylet handle member 16 is disconnected from the cannula handle member 18 by rotation through about 90° with respect to the cannula handle member.
- the stylet handle member 16 is then moved axially away from the cannula handle member 18 so that the stylet shaft 20 slides out of the cannula shaft 22 while the cannula shaft remains in the bone (see, FIG. 3 ).
- the spring 52 (“shield release device 50 ”) moves the stylet shield 26 distally along the stylet shaft 20 the distance D from its initial position ( FIG. 7 ). Stated another way, the stylet shield 26 is moved by the spring 52 from its FIG. 6 position to its FIG. 7 position.
- the technician grasps the exposed distal end portion of the stylet shield 26 . Grasping the distal end of the shield 26 is facilitated by its advancement out of the stylet cavity 44 by the spring 52 .
- the technician then slides the safety shield 26 distally along the stylet shaft 20 until the locking mechanism 32 trips and locks the shield over the sharp distal tip 28 of the shaft.
- the safety shield 26 is shown at an intermediate position sliding down the stylet shaft 20 in FIG. 4 and in the locked position at the end of the shaft in FIG. 5 .
- the cannula handle member 18 With the distal tip of the stylet shaft 20 safely covered by the shield 26 , the cannula handle member 18 is advanced further into the bone to collect a sample of marrow, if marrow collection is the desired operation.
- the sharp tip 28 of the cannula 14 cuts into the bone marrow and a sample is received in the central axial passage of the cannula shaft 22 .
- the cannula 14 can then be withdrawn from the patient by pulling on the cannula handle member 24 .
- the sample should remain lodged in the central axial passage of the cannula shaft 22 .
- An obturator (not shown) is then inserted into the distal tip of the cannula shaft 22 to dislodge the sample and force it out the proximal open end of the cannula shaft.
- the cannula safety shield 70 is then moved distally along the cannula shaft 22 until the locking mechanism in the shield (not shown) locks the shield over the tip of the shaft.
- a needle assembly may be used to collect a sample other than of bone marrow within the scope of the present invention.
- the cannula as located within the bone may be used for fluid injection or aspiration from the intramedulary canal.
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- Orthopedic Medicine & Surgery (AREA)
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Abstract
Description
Claims (16)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/933,864 US8357104B2 (en) | 2007-11-01 | 2007-11-01 | Active stylet safety shield |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/933,864 US8357104B2 (en) | 2007-11-01 | 2007-11-01 | Active stylet safety shield |
Publications (2)
Publication Number | Publication Date |
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US20090118639A1 US20090118639A1 (en) | 2009-05-07 |
US8357104B2 true US8357104B2 (en) | 2013-01-22 |
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US11/933,864 Active 2030-06-20 US8357104B2 (en) | 2007-11-01 | 2007-11-01 | Active stylet safety shield |
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Cited By (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9072823B2 (en) | 2012-05-16 | 2015-07-07 | The Seaberg Company, Inc. | Safety needle |
USD735332S1 (en) | 2013-03-06 | 2015-07-28 | C. R. Bard, Inc. | Biopsy device |
USD735333S1 (en) | 2013-06-26 | 2015-07-28 | C. R. Bard, Inc. | Biopsy device |
USD737440S1 (en) | 2013-03-07 | 2015-08-25 | C. R. Bard, Inc. | Biopsy device |
US9579468B2 (en) | 2011-11-07 | 2017-02-28 | Safety Syringes, Inc. | Contact trigger release needle guard |
US9925068B2 (en) | 2014-05-30 | 2018-03-27 | Treace Medical Concepts, Inc. | Bone harvester and bone marrow removal system and method |
US9968338B2 (en) | 2012-11-21 | 2018-05-15 | C. R. Bard, Inc. | Core needle biopsy device |
US20190083275A1 (en) * | 2017-09-15 | 2019-03-21 | Stryker European Holdings I, Llc | Intervertebral Body Fusion Device Expanded With Hardening Material |
US10543018B2 (en) | 2015-05-15 | 2020-01-28 | Covidien Lp | Surgical access device |
US11278319B2 (en) | 2018-07-11 | 2022-03-22 | Boston Scientific Scimed, Inc. | Expandable medical device for use with a needle |
Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9924898B2 (en) * | 2008-04-15 | 2018-03-27 | Becton, Dickinson And Company | Flash activated passive shielding needle assembly |
BR112019007804B1 (en) | 2016-10-18 | 2023-04-25 | Piper Access, Llc | INTRAOSSEAL ACCESS SYSTEM |
JP7065846B2 (en) | 2016-10-27 | 2022-05-12 | シー・アール・バード・インコーポレーテッド | Intraosseous access device |
ES2880417T3 (en) | 2017-03-07 | 2021-11-24 | Piper Access Llc | Safety protection elements for elongated instruments and related systems |
CN110381856B (en) | 2017-03-10 | 2023-05-16 | 派柏阿克塞斯有限责任公司 | Fixing device, system and method |
WO2019164990A1 (en) | 2018-02-20 | 2019-08-29 | Piper Access, Llc | Drilling devices and related methods |
CA3098894A1 (en) * | 2018-05-01 | 2019-11-07 | Becton, Dickinson And Company | Squeeze activated blood collection set |
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